Public health-friendly options for protecting pharmaceutical registration data
by Robert Weissman
International Journal of Intellectual Property Management (IJIPM), Vol. 1, No. 1/2, 2006

Abstract: To gain marketing approval, generic firms typically rely on the clinical safety and efficacy testing data that brand-name pharmaceutical companies previously submitted (''registration data''). Big Pharma and the US government are pushing developing countries to provide brand-name companies with a minimum of five years exclusive rights to registration data. But restrictions on use of registration data delay the introduction of price-lowering generic competition. This paper considers public-health friendly alternatives, emphasising a cost-sharing approach, in which generic firms have an absolute right to use registration data, but must pay a proportionate share of the cost of generating the data.

Online publication date: Tue, 03-Oct-2006

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